Pharmacovigilance Assessment

The scope of the SOP does not need to clearly state that it applies to adverse events that occur at sites/organisation/institution:

True

False

Accidental intravenous injection of __________ can lead to fatal cardiac arrhythmias.

Phenylephrine

Lidocaine

Epinephrine

Bupivacaine

A mathematical model to assess many factors is

Propensity score

Multivariate analysis

Sensitivity analysis

None of these

Signal Documents are automatically reassessed:

Every year

Six-monthly basis, for two years

Quarterly basis, every year

Quarterly basis, for two years

Any untoward medical occurrence n a patient or clinical trial subject administered a pharmaceutical product and which does not necessarily have to have a causal relation with this treatment is known as

Regulatory reporting for multiple case reports over a specified time period is termed as:

Aggregate Reporting

Expedited Reporting

Interim Reporting

All of these

Epidemiological investigations focus on

Determining when the exposure

Identifying the exposure

Identifying cases

All of these

According to Schedule-Y, sponsor should report SAE to - Regulatory Authorities as well as to all Investigators participating in trial within:

7 calendar days

14 working days

7 working days

24 hours

14 calendar days

ADRs in Clinical Trials can be detected by :

Adverse drug event questionnaire

Computerized screening

Medication order screening

None of these

The PSUR usually include:

Formulation

Dosage forms

Indications

All of these

As per WHO definitions, A clinical event, including a laboratory test abnormality, with a reasonable time sequence to administration of the drug but which could also be explained by concurrent disease or other drugs or chemicals is known as_______________.

Probable

Possible

Certain

Conditional

Each SUSAR report is identified by which of the following?

Sponsor protocol code number

Sponsor’s case number

EUDRACT number

Suspected product information

Study subject code

All of these

The process of electronically receiving a case within Argus Safety after it has been physically received by the Drug Safety team is called: